Oncology

Grand Rounds February 14, 2025: A Clustered-Randomized Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults with Cancer (ACP PEACE) (Angelo Volandes, MD, MPH; James A. Tulsky, MD)

Posted on by Sophia Ramirez

Speakers

Angelo Volandes, MD, MPH
Vice Chair of Research, Department of Medicine
Dartmouth Health
Professor of Medicine, Geisel School of Medicine

James A. Tulsky, MD
Poorvu Jaffe Chair, Department of Supportive Oncology
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School

Keywords

Palliative Care; Goals of Care; Advanced Care Planning; Cancer; Oncology

Key Points

  • Cancer is one of the leading causes of death for people age 65 and older, and patients have diverse preferences for medical care. However, most patients are unfamiliar with advance care planning (ACP) and clinicians are often unprepared to discuss it. Ultimately, many patients do not have goals-of-care (GOC) conversations with their providers, leading to billions of dollars in unwanted (and painful) interventions.
  • The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE) trial tested a pair of interventions – ACP Decisions and Vitaltalk – to help prepare clinicians and elderly patients to have GOC conversations.
  • ACP Decisions consists of short, accessible video decision aids that aim to help patients share in decision making. They offer a scalable, speedy strategy to improve GOC, and were associated with an increase in GOC conversations in smaller trials.
  • Vitaltalk is a communication training for clinicians discussing goals of care in serious illness. It is evidence-based, designed around the idea that learning new skills requires practice, observation, and feedback. Vitaltalk is associated with documented improvement in conversation quality.
  • ACP PEACE was a large, pragmatic, multicenter stepped-wedge trial that compared an intervention period and a control period, AKA usual care. The trial occurred across three healthcare systems (A, B, and C) and began with 36 clinics, 6 months before the onset of the COVID-19 pandemic. In April 2020, the trial was re-randomized across 29 clinics.
  • Participants were 65 and older with advanced cancer. The primary endpoint was documentation of a GOC conversation.
  • The study team found a 6.8% increase in ACP documentation during the intervention period, driven by a 6.9% increase in documented GOC conversations. There was no statistically significant increase in documentation of referrals to palliative care or to hospice. There was no statistically significant decrease in the limitation of life-sustaining treatments.
  • The results varied significantly by healthcare system. In Healthcare System A, documentation decreased by nearly 8% over the course of the study – whereas in Healthcare Systems B and C, it increased by 11% and 8.3%, respectively.
  • The researchers considered whether GOC conversation documentation was the right target. There has been a conversation in palliative care about how helpful these documents are; goal-aligned medical care (goal concordance) might be a better target.
  • Volandes and Tulsky noted that the approach to pragmatic clinical trials should better reflect the shifting nature of healthcare in the U.S. Researchers in this space must be better stewards of limited resources, so that interventions are sustainable and outcomes are useful to decision-makers.

Discussion Themes

Efforts to enhance rigor in intervention development may prevent effective interventions from getting to scale. Leaders in this space need to make it easier to get implement and test interventions, even if that means they aren’t perfectly optimized.

Right now, researchers are disincentivized to move quickly during the UG3 start-up year. Funders could incentivize research teams to move more quickly, e.g., by encouraging them to use leftover funds to conduct another study.

People in healthcare don’t see 10 years ahead – they see 1 to 2 years ahead. If pragmatic trials are meant to inform decision makers, it’s incumbent on researchers to provide the information healthcare systems need in a manner that is not outdated.

Ongoing partnerships with appropriate health systems can provide a platform for more efficient intervention implementation across different areas of healthcare. For instance, the research team conducted three other trials in Healthcare System C within the time it took them to complete ACP PEACE.